TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 11 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

Safety Assessment all along the observation period (Day-1 to Day-240): Safety assessment will include vital signs, adverse events and concomitant medications collection as well as biology during the 6 months of the treatment period; .In addition, the evolution of the disease will be followed 2,5 months after IL2- treatment stop.

Protocol: TRANSREG is a multicentric, uncontrolled, open-label study, comparing biological and clinical responses to the administration of low doses IL2 across 11 selected pathologies: rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Behcet's disease, Wegener's granulomatosis, Takayasu's disease, Crohn's disease, ulcerative colitis, autoimmune hepatitis, and sclerosing cholangitis.Methods: Each patient will receive 1MUI /day of IL2 from Day-1 to Day-5 (the induction period), and then every 2 weeks from Day-15 to Day-180 (the maintenance period). Patients will thereafter be followed up for 2 months (Day-181-Day-240). For each pathology, 6 patients will be included at Pitié-Salpêtrière, Cochin and Saint Antoine hospitals in Paris. An interim analysis will be performed in each pathology group when the first six patients have received at least 3 months of treatment. In those pathology groups in which a Treg response will be documented, six additional patients will be included. In total, a minimum of 66 patients and up to 132 patients will be enrolled in this study. Primary efficacy endpoint is the Treg response at Day-8. Secondary endpoints are:- the Treg response during the maintenance period,- the changes in markers of inflammation - the clinical response, evaluated by means of global generic scales [Clinical Global Impression severity scale (CGI-sev) and Clinical Global Impression efficacy index (CGI-eff)] as well as specific clinical and biological evaluations for each disease, - the frequency of relapses, - the assessment of quality of life (scale EuroQL-5).Expected Results: TRANSREG will define which patients respond to IL2, whether per pathology or according to pre-treatment phenomics, allowing to guide further clinical development of low dose IL2 in autoimmune and auto-inflammatory diseases.

significant abnormality in chest X-ray other than these linked to the diseases under investigation

cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or basocellular carcinoma)

poor venous access not allowing repeated blood tests,

restrictive diet or parenteral nutrition,

surgery during the last 2 months or surgery planned during the study,

participation in other biomedical research in the last 3 months or planned during the study.

pregnant or lactating women,

concomitant psychiatric disease or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give informed consent,

positive HIV serology, active hepatitis B or EBV infection,

patients under a measure of legal protection

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988506